Status:
UNKNOWN
Oxford Niaspan Study: Effects of Niaspan on Atherosclerosis and Endothelial Function
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
Merck KGaA, Darmstadt, Germany
Conditions:
Atherosclerosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
AIM 1 will test the hypothesis that elevation of high-density lipoprotein (HDL) through treatment with Niaspan will accelerate the regression of atherosclerotic plaque in patients with established ath...
Detailed Description
Patients will be randomised to receive either Niaspan 2000mg each night or placebo. Niaspan will be commenced at 375mg daily and increased to 500mg then to 750, and 1000mg daily at weekly intervals. A...
Eligibility Criteria
Inclusion
- Aim 1: Carotid or peripheral arterial disease and HDL \<1mmol/L
- Aim 2: Coronary artery disease, type II diabetes and HDL \<1mmol/L
Exclusion
- The following will constitute exclusion criteria:
- Inability to provide informed consent,
- Known intolerance of a study drug,
- Use of niacin or a fibrate at time of screening,
- AST or ALT elevated above normal range at time of screening
- Use of oral nitrates or nicorandil
- Uncontrolled or newly diagnosed diabetes mellitus
- Symptomatic heart failure or heart failure requiring treatment with diuretics
- Fasting triglycerides \> 500mg/dL \[5.65mmol/L\]
- Patients with acute coronary syndromes, active peptic ulcer disease,
- Active gout,
- Standard exclusions for MRI will apply, i.e. pacemakers, implantable defibrillators, metal implants or embedded metallic fragments of any kind.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00232531
Start Date
September 1 2004
End Date
February 1 2009
Last Update
January 29 2007
Active Locations (1)
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1
Oxford University
Oxford, United Kingdom